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Immunogenicity and Safety of DTP-HB-Hib Using New Hepatitis B Bulk (Bio Farma)

NCT05482282 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2025-06-05

No results posted yet for this study

Summary

This bridging study is a randomized, double-blind, two arms parallel group, prospective intervention study. The primary objective of this study is to evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) using new Hepatitis B bulk (Bio Farma).

Conditions

  • Diphtheria Vaccine Adverse Reaction
  • Tetanus Vaccine Adverse Reaction
  • Pertussis Vaccine Adverse Reaction
  • Haemophilus Influenzae Type B Vaccine Adverse Reaction
  • Hepatitis B Vaccine Adverse Reaction

Interventions

BIOLOGICAL

Recombinant Hepatitis B new Bulk vaccine

1 dose of Recombinant Hepatitis B vaccine using new Hepatitis B bulk (Bio Farma) 1 dose of 0.5 ml Recombinant Hepatitis B new Bulk vaccine dose of DTP-HB-Hib using new Hepatitis B Bulk vaccine injected intramuscularly into the left external antero-lateral thigh region.

BIOLOGICAL

DTP-HB-Hib with Recombinant Hepatitis B new Bulk vaccine

3 doses of DTP-HB-Hib with Recombinant Hepatitis B new Bulk vaccine

BIOLOGICAL

Recombinant Hepatitis B vaccine (Registered BioFarma)

1 dose of Recombinant Hepatitis B vaccine (Registered Bio Farma)

BIOLOGICAL

Pentabio

3 doses of Pentabio

Sponsors & Collaborators

  • Hasan Sadikin General Hospital

    collaborator OTHER

  • PT Bio Farma

    lead INDUSTRY

Principal Investigators

  • Eddy Fadlyana, MD · Hasan Sadikin General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
3 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05482282 on ClinicalTrials.gov